“Distribution Through the Public Sector” means Distribution, disposition or use of CAMB in the Territory for use in the Field by a Public Sector Agency.
2. RESEARCH AND DEVELOPMENT PROGRAM
2.4 BDSI’s Performance of the R&D Plan
(a) Research and Development Activities. BDSI agrees to use its best efforts to perform or have performed at its own cost the responsibilities assigned to it in the R&D Plan and Project Plans, all in accordance therewith and in a manner consistent with any timelines set forth therein. In particular, BDSI agrees to dedicate the appropriate number of FTEs to perform the tasks described in the R&D Plan. BDSI will ensure that its responsibilities under the R&D Plan and Project Plans are conducted in compliance with all applicable Laws or guidelines pertaining to good research practices and/or good laboratory practices.
(c) Clinical Product Supply. BDSI will manufacture and make available to DNDi samples of CAMB in such quantities as shall be necessary for DNDi to conduct its activities under the R&D Plan. Such samples will be subject to the provisions of Section 2.6 below and sold by BDSI to DNDi at a price to be agreed between the Parties once agreement on clinical trial protocols have been reached by the JRC. DNDi and BDSI management will base the cost of clinical trial materials on the cost of the raw materials necessary for the production of CAMB and agree to a reasonable and sufficient additional cost to cover BDSI’s internal costs or the costs of using an external manufacturer. DNDi acknowledges (a) any or all of BDSI’s supply obligations hereunder can be supplied by Third Party subcontractors which will provide the necessary staff, equipment, instruments, raw materials and facilities to carry out BDSI’s manufacturing obligations, (b) BDSI will remain responsible for the conduct of all of its obligations under this Agreement, including those conducted by such Third Party subcontractors and DNDi will have no responsibility for managing such activities or such subcontractors, (c) BDSI will keep the JRC informed of any Third Party subcontractor which BDSI engages to perform its obligations under this section of the Agreement.
3. REGULATORY APPROVALS, MANUFACTURE AND DISTRIBUTION
3.3 Manufacture and Supply. During the Term and subject to the provisions of Section 4.1, BDSI will be responsible for the exclusive, subject to section 3.3 (a), manufacture and supply of CAMB to DNDi for Distribution in the Territory and for all costs associated therewith. Prices at which BDSI will sell CAMB to DNDi are set out in section 5.3 below.
(a) Should BDSI be unable to meet DNDi’s Distribution needs as evidenced by failure to meet *** of DNDi’s forecast needs for *** consecutive quarters, DNDi shall be able to engage a secondary supplier to meet any BDSI shortfall in DNDi’s supply needs with the assistance of BDSI. However, in every instance, DNDi shall purchase the full quantity of CAMB available from BDSI prior to engaging a secondary manufacturer. Should DNDi engage a secondary supplier due to BDSI shortfall of DNDi’s Distribution needs, DNDi will revert back to BDSI as the exclusive supplier of DNDi’s needs once BDSI is able to show manufacturing capacity equivalent to *** of DNDi’s forecast needs for any upcoming quarter.
4.1 Licenses to DNDi. Subject to all of the terms and conditions of this Agreement, BDSI hereby grants DNDi: […]
(b) an non–exclusive, royalty–free, irrevocable and fully paid–in, sublicensable (as permitted under Section 4.3) license to use BDSI Background IP and Collaboration IPR for the purpose of seeking Regulatory Approvals and undertaking Distribution Through the Public Sector in the Territory for use in the Field; provided, however that if, for any reason, BDSI is unable to supply CAMB ordered by DNDi or its nominee for Distribution Through the Public Sector, for use in the Field, in the Territory, this exclusive license shall be automatically extended to include the right for DNDi to manufacture CAMB, or to have CAMB manufactured by any Third Party, for the sole purpose of its Distribution Through the Public Sector in the Territory for use in the Field, subject to section 3.3.